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Angiotensin II Antagonism of TGF-Beta 1

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ClinicalTrials.gov Identifier: NCT00320970
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : August 2, 2007
Information provided by:
Providence Health & Services

Brief Summary:
Diabetic nephropathy is a frequent microvascular complication that occurs in approximately 40% of patients with either type 1 or type 2 diabetes. The most common cause of end-stage renal disease (ESRD) in the United States and in the developed world is diabetic nephropathy. Currently, more than half the United States ESRD population has diabetes. More effective therapies to prevent and treat diabetic nephropathy are urgently needed. One way to increase therapeutic effectiveness is to refine treatment targets based on improved understanding of how treatments modulate disease processes. The purpose of this study is to determine whether a treatment for diabetic nephropathy, the angiotensin receptor blocker candesartan, modifies mediators of kidney injury independent of blood pressure and the relationships to drug dose.

Condition or disease Intervention/treatment
Diabetic Nephropathy Hypertension Drug: Candesartan

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Angiotensin II Antagonism of TGF-Beta 1: A Candesartan Dose - TGF-Beta 1 Response Relationship Study
Study Start Date : August 2002
Estimated Study Completion Date : September 2004

Primary Outcome Measures :
  1. Blood pressure
  2. Urinary TGF-Beta 1
  3. Serum angiotensin II
  4. Urinary albumin
  5. Urinary carboxymethyllysine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Type 2 diabetes
  • Nephropathy (proteinuria >500 mg/day)
  • Chronic Hypertension (as determined by current antihypertensive therapy and/or an average of diastolic blood pressure greater than 90 mmHg or greater or systolic blood pressure of 140 mmHg confirmed on at least two subsequent visits over one week or more).

Exclusion Criteria:

  • Conditions associated with elevated TGF-Beta (e.g. rheumatoid arthritis, cancer, etc.).
  • Conditions associated with alterations in serum levels of PIP and/or CITP (liver cirrhosis, osteoporosis, hyperthyroidism, multiple myeloma, osteolytic metastases, and systemic glucocorticoid treatment
  • History of Stage III hypertension (diastolic BP > 110 mmHg or systolic BP > 180 mmHg) or a history of hypertensive urgency or emergency.
  • NYHA Class III or IV heart failure
  • Calculated creatinine clearance of less than 30 ml/min or serum creatinine > 3 mg/dL
  • HbA1c > 10%
  • Patients unable to be withdrawn for 2 weeks from AT-II antagonist or ACE- inhibitor therapy
  • Blood Pressure <140/90 is unachievable in the absence of an AT-II antagonist or ACE-inhibitor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00320970

United States, Washington
Providence Medical Research Center
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Providence Health & Services
Principal Investigator: Katherine R. Tuttle, MD,FASN,FACP Providence Medical Research Center

ClinicalTrials.gov Identifier: NCT00320970     History of Changes
Other Study ID Numbers: HI831
First Posted: May 3, 2006    Key Record Dates
Last Update Posted: August 2, 2007
Last Verified: March 2006

Keywords provided by Providence Health & Services:
TGF-Beta 1
Angiotensin II
Advanced glycation end products

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Candesartan cilexetil
Angiotensin II
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors